European Regulatory Affairs
|Event Date/Time: Jun 04, 2007||End Date/Time: Jun 05, 2007|
The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail.
The workshop will provide strategic advice on how to file applications for the marketing authorizations in the European Union for staff involved in International Regulatory Affairs.
•Mutual Recognition Procedure
•Key Issues to Consider for Business Opportunities
•Legal Status of Products and Switching from Rx to OTC
•Medical Devices Legislation
•Clinical Trial Directive.